New HAE Drug Candidate from Dyax Produced by Laureate Biopharma High-Titer Process Developed for New Antibody Therapeutic
PRINCETON, N.J., Aug. 26, 2013 /PRNewswire/ -- Laureate Biopharma is pleased to announce its successful collaboration with Dyax Corp. for process development and cGMP production of a new treatment candidate for hereditary angioedema (HAE). The drug candidate, known as DX-2930, is a fully human IgG antibody designed to prevent HAE attacks by inhibition of plasma kallikrein. Dyax, a biopharmaceutical company focused on HAE and other plasma kallikrein disorders, recently announced the start of a Phase 1 clinical trial evaluating the safety and tolerability of DX-2930.
In working with the cell line producing DX-2930, Laureate's scientists were able to successfully scale-up and manufacture a high-titer antibody process. This process was amendable to cGMP production in both stainless-steel and single-use bioreactors. Application of Laureate's platform downstream process for IgG antibodies led to high protein recovery and purity. Aseptic filling, a routine operation at Laureate, produced the clinical drug product in 98% yield. Finally, careful project management of the program by both companies resulted in the successful release of bulk drug substance.
"Entry into human subjects is an important milestone for the DX-2930 development program," said Gustav Christensen, President and CEO of Dyax. "It was a pleasure to work with Laureate's scientific and program management team. This valuable partnership has enabled us to advance this fully human monoclonal antibody into the clinic and closer toward our goal of a new therapeutic for the prevention of HAE attacks."
"This project showcased Laureate's scientific expertise in rapid development of efficient, high-yielding processes for clinical production of therapeutic antibodies," noted Michiel E. Ultee, Ph.D., Laureate's Chief Scientific Officer. "Our scientists have produced a wide variety of antibodies for more than 30 years, including IgG, IgM, fragmented (Fab & F(ab')2), conjugated, aglycosylated and domain-deleted antibodies."
About Laureate Biopharmaceutical Services, Inc.
Laureate Biopharmaceutical Services, Inc. is a full-service biopharmaceutical contract development and manufacturing organization. Laureate Biopharma's scientists are expert in process development and cGMP production of therapeutic proteins including monoclonal antibodies and Fc-fusion proteins. In addition, the company's portfolio of services includes aseptic filling, cell line development, analytical and stability testing, and regulatory support. Laureate Biopharma has served a global client base from its Princeton, New Jersey facility since 1981 and is a portfolio company of Saints Capital, LLC. For more information, please visit www.LBioS.com.
Dyax is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs. The Company's key value drivers are the KALBITOR® (ecallantide) business, DX-2930 and the Licensing and Funded Research Program (LFRP).
For additional information about Dyax, please visit www.dyax.com.
For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com.
SOURCE Laureate Biopharma